Blood Factors and Diabetic Retinopathy

June 30, 2017 updated by: National Eye Institute (NEI)

Study of Association of Serum Factors With Diabetic Retinopathy

This study will determine whether certain factors in the blood are associated with the severity of diabetic retinopathy.

Patients age 10 years and older with diabetes mellitus and diabetic retinopathy may be eligible for this study. Those enrolled will represent a range of diabetic retinopathy from minimal to severe. Participants will undergo the following procedures:

  • medical history
  • thorough eye examination
  • photographs of the eye
  • blood tests to measure blood lipids (cholesterol and triglycerides) and serum creatinine (for kidney function)
  • blood tests to measure levels of blood factors (cell adhesion molecules, chemokines and vascular endothelial growth factor) that may be related to the progression of diabetic retinopathy
  • blood pressure measurement
  • urinalysis

This study may lead to a better understanding of how diabetic retinopathy develops and progresses.

Study Overview

Status

Completed

Conditions

Detailed Description

Participants with a range of severity of diabetic retinopathy and healthy volunteers will be evaluated once for serum levels of cell adhesion molecules, chemokines and vascular endothelial growth factor. This study may lead to a better understanding of the pathogenesis of diabetic retinopathy and the identifying of possible targets for treatment. All study participants will undergo an ocular exam and ophthalmic photography. Blood is drawn for the analysis of these serum factors.

Study Type

Observational

Enrollment (Actual)

173

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • VOLUNTEER INCLUSION CRITERIA:

Volunteers will be able to enroll if they:

  • Have the ability to understand and sign an informed consent.
  • Are able and willing to give a blood sample.
  • Are healthy as determined by study Investigator.
  • Have no chronic diseases.
  • Do not exhibit any clinical indications of diabetes.

PARTICIPANT INCLUSION CRITERIA:

Participants will be able to enroll if they:

  • Have the ability to understand and sign an informed consent.
  • Are able and willing to give a blood sample.

  • Have a clinical diagnosis of diabetes based on any one of the following criteria:

    1. Documented history of plasma glucose value greater than or equal to 210 mg/dl on three different occasions.
    2. Fasting blood sugar greater than or equal to 150 mg/dl on three different occasions.
    3. Documented history of ketoacidosis.
    4. Insulin dependency.
    5. Documented history of abnormal glucose tolerance test.

EXCLUSION CRITERIA:

Neither volunteers nor participants will be eligible if they:

  • Are under the age of 10.
  • Have severe systemic disease(s) that compromise our ability to obtain an adequate examination.

  • Have any of the following ocular characteristics or conditions in both eyes:

    1. Opacities of the ocular media, limitations or pupillary dilation or any other problems sufficient to preclude good, quality stereo fundus photographs.
    2. Ocular disease which confounds assessment of diabetic retinopathy such as advanced age-related macular degeneration, central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration.
    3. Chronic requirement for any ocular medication for other diseases, such as glaucoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 23, 2000

Study Completion

December 7, 2010

Study Registration Dates

First Submitted

May 26, 2000

First Submitted That Met QC Criteria

May 26, 2000

First Posted (Estimate)

May 29, 2000

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

December 7, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000135
  • 00-EI-0135

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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